Effect of Nasaleze on Nasal Challenge With Allergen

Allergic Rhinitis Clinical Trial

Official title:

Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01723397
• Other study ID #: 12-1252
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: September 27, 2013
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: James Lane, BS
• Phone: 773-702-5889
• Email: jlane[@]surgery.bsd.uchicago.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objectives of this protocol are:

1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and

2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria

1. Males and females between 18 and 45 years of age.

2. History of grass and/or ragweed allergic rhinitis.

3. Positive skin test to grass and/or ragweed antigen.

4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

2. Pregnant or lactating women.

3. Upper respiratory infection within 14 days of study start.

4. FEV1<80% of predicted at screening for subjects with history of mild asthma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Device:
• Nasaleze Spray device

• Placebo

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Nasaleze

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total nasal symptoms	The difference in change in total nasal symptoms after the antigen challenges on the second day	2 weeks	No